FDA approves Coagadex for hereditary Factor X deficiency

The US Food and Drug Administration (FDA) has approved Bio Products Laboratory’s Coagadex (Coagulation Factor X (Human)) for hereditary Factor X deficiency.

Until this orphan drug approval, no specific coagulation factor replacement therapy was available in the US for patients with hereditary Factor X deficiency.

Factor X deficiency is an inherited disorder, affecting men and women equally, where the blood does not clot as it should. Patients with the disorder are usually treated with fresh-frozen plasma or plasma-derived prothrombin complex concentrates to stop or prevent bleeding. The availability of a purified Factor X concentrate increases treatment options for patients with this rare bleeding disorder.

Coagadex approval a “significant advancement” for patients with hereditary Factor X deficiency

“The approval of Coagadex is a significant advancement for patients who suffer from this rare but serious disease,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research.    

Coagadex, which is derived from human plasma, is indicated for individuals aged 12 and older with hereditary Factor X deficiency for on-demand treatment and control of bleeding episodes, and for perioperative management of bleeding in patients with mild hereditary Factor X deficiency.

The safety and efficacy of Coagadex was evaluated in a study involving 16 participants for treatment of spontaneous, traumatic and heavy menstrual bleeding episodes. Coagadex was demonstrated to be effective in controlling bleeding episodes in participants with moderate to severe hereditary Factor X deficiency. Coagadex was also evaluated in five participants with mild to severe Factor X deficiency who were undergoing surgery. The five individuals received Coagadex for perioperative management of seven surgical procedures. Coagadex was demonstrated to be effective in controlling blood loss during and after surgery in participants with mild deficiency.